Stable aqueous formulations of adalimumab
DCFirst Claim
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1. A stable aqueous pharmaceutical composition comprising:
- a) adalimumab;
b) a buffer;
c) polysorbate 80; and
d) a sugar,wherein the composition is free of i) mannitol, ii) citrate and phosphate buffers, and iii) sodium chloride and wherein the composition has a pH of about 5 to about 6.
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Abstract
The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.
117 Citations
12 Claims
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1. A stable aqueous pharmaceutical composition comprising:
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a) adalimumab; b) a buffer; c) polysorbate 80; and d) a sugar, wherein the composition is free of i) mannitol, ii) citrate and phosphate buffers, and iii) sodium chloride and wherein the composition has a pH of about 5 to about 6. - View Dependent Claims (2, 3, 4)
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5. A stable aqueous pharmaceutical composition comprising:
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a) adalimumab; b) a buffer; c) polysorbate 80; and d) sucrose, wherein the composition is free of i) mannitol, ii) citrate and phosphate buffers, and iii) sodium chloride and wherein the composition has a pH of about 5 to about 6. - View Dependent Claims (6, 7, 8)
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9. A stable aqueous pharmaceutical composition comprising:
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a) adalimumab; b) acetate buffer; c) polysorbate 80; and d) sucrose, wherein the composition is free of i) mannitol, ii) citrate and phosphate buffers, and iii) sodium chloride and wherein the composition has a pH of about 5 to about 6. - View Dependent Claims (10, 11, 12)
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Specification